Active substance: tenofovir disoproxil The company Gilead Sciences GmbH is circulating information on incorrect dosage information in the Summaries of Product Characteristics of Viread 204 mg film-coated tablets.

Active substance: Valproate A notice of annulment was sent out for medicinal products for which the marketing authorisation holder had renounced the marketing authorisation.

Active substance: dantrolene The company Norgine GmbH is circulating information that as of April 2017 (the 12 vial pack) or May 2017 (the 36 vial pack), packages of Dantrolen i.v. newly placed on the market no longer contain water for injection. Care must be taken that there is always a sufficient amount of water for injection on hand for reconstituting the solution.

Active substance: crisantaspase The company Jazz Pharmaceuticals Germany GmbH is circulating information on the fact that, due to a temporary shortage, Erwinase® 10.000 I.U./vial powder for solution for injection is currently only available under consideration of the provisions of Section 73 (3) AMG. In connection with the import of Erwinase® from The United Kingdom, the company is also issuing information on the fact that a 5 μm filter needle is to be used when administering batches 179a* and 180a*.

Active substance: enoxaparin sodium The company Sanofi-Aventis Deutschland GmbH is sending out information that the information on the effective strength of the medicinal product, the dosage recommendation for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) as well as the recommendations for use in patients with severe renal impairment has been updated.

Active substance: Epinephrin In coordination with the competent supervisory authority, the regional council ("Regierungspräsidium") in Darmstadt, the company Meda Pharma GmbH & Co. KG has initiated a voluntary recall of the listed batches of the adrenaline autoinjector Fastjekt® and Fastjekt® Junior in Germany.

Active substance: valproate In view of renewed discussions and assessments on a European level as well as current findings and discussions with scientific societies, the BfArM also considers it necessary to introduce a patient alert card as a further measure in addition to previous risk minimisation measures. The following notice in this regard was prepared after the hearing of 1 March 2017.

Active substance: dienogest, ethinylestradiol In its notice of 5 April 2017, the Federal Institute for Drugs and Medical Devices (BfArM) has ruled the realisation of the corresponding implementing decision of the EU Commission C(2017) 2057 final of 22 March 2017. The European safety review according to Article 31 of Directive 2001/83/EC regarding medicinal products containing dienogest 2 mg und ethinylestradiol 0.03 mg is thus now concluded.

Active substance: retigabin The company GlaxoSmithKline GmbH & CO KG is sending out information that as of the end of June 2017, all strengths of the medicinal product Trobalt® (retigabine) will be discontinued on a worldwide level and will thus cease to be available. The medicinal product was already withdrawn from the German market on 1 July 2012. However, based on company information, several patients in Germany are still being treated with imported products from other European countries which is why physicians in Germany will also be circulating the corresponding information.

Active substance: cobimetinib The company Roche Pharma AG is sending out information on the risk of haemorrhage and rhabdomyolysis as well as new recommendations on dose modifications when taking Cotellic® (cobimetinib). Prior to initiating treatment, serum CPK and creatinine levels should be determined and subsequently monitored monthly during treatment or as clinically indicated. In cases of increased serum CPK levels, it must be evaluated whether the signs and symptoms are due to rhabdomyolysis or whether other causes are present.

Active substances: daclatasvir | dasabuvir | sofosbuvir/ledipasvir | simeprevir | sofosbuvir | ombitasvir/paritaprevir/ritonavir The European Medicines Agency (EMA) confirms its recommendation for hepatitis B screening of all patients before starting treatment with direct-acting antiviral drugs for the treatment of hepatitis C

Active substance: sofosbuvir, velpatasvir The Federal Institute for Drugs and Medical Devices (BfArM) reports that a counterfeit of the company Gilead's medicinal product Epclusa® 400 mg/100 mg film-coated tablets was offered to a wholesaler in Germany.

Active substance: selexipag The company Actelion Pharmaceuticals Deutschland GMBH is circulating information that a contraindication for concomitant administration of Uptravi® (selexipag) and strong inhibitors of CYP2C8 (e.g. gemfibrozil) has been introduced.

Active substance: escherichia coli In its review of Symbioflor 2, the European Medicines Agency EMA has concluded that the medicinal product can continue to be used for treatment of irritable bowel syndrome in adults. However, it should no longer be taken to treat so-called functional gastrointestinal disorders.

Active substance: valproate and related substances In a notice dated 10 April 2017, the Federal Institute for Drugs and Medical Devices (BfArM) ruled the introduction of a patient alert card for medicinal products containing valproate as a supplementary risk minimisation measure. The companies concerned have issued a corresponding information letter.